Hospira, Inc., a Pfizer company, issued a voluntary recall of one lot of, Magnesium Sulfate in Water for Injection, to the user level after a confirmed customer report of an incorrect barcode on the primary bag labeling, according to the FDA.
The product has a barcode identifying the product contents on both the overwrap and on the primary container. The barcode on the overwrap is correct. However, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin sodium 2000 usp units/1000 mL in 0.9% sodium chloride injection.
The product is labeled with the correct printed name on the primary container and overwrap. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
If the incorrect barcode on Magnesium Sulfate in Water for Injection, is not detected prior to dispensing or administration to a patient, and the product is administered based on the printed name, patient harm is unlikely since the barcode on the overwrap and readable text on the primary container and overwrap are correct.
However, if detected, there is the potential for delay in treatment of Magnesium Sulfate in Water for Injection that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.